FDA WARNING_LETTER - Nutrishare Inc - May 26, 2017

The FDA issued a Warning Letter to Nutrishare, Inc. following a May 22-26, 2017 inspection of their Louisville, KY facility, which uncovered serious deficiencies in sterile drug product manufacturing. The inspection resulted in a Form FDA 483, and the firm's subsequent June 19, 2017 response was deemed inadequate. The primary violation identified was that sterile drug products were prepared, packed, or held under insanitary conditions, leading to adulteration under section 501(a)(2)(A) of the FDCA. Specific examples included using non-sterile wipes for ISO 5 hoods and personnel introducing exposed skin into critical areas. These adulterated drugs, when introduced into interstate commerce or held for sale after interstate shipment, constitute prohibited acts under FDCA sections 301(a) and 301(k). The FDA noted that Nutrishare's response failed to adequately address these insanitary conditions and poor aseptic techniques, despite claiming USP 797 compliance. The Agency strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with the assistance of a third-party consultant. Additionally, concerns were raised about two wall-mounted air conditioning units in the (b)(4) room, identified as potential sources of microbial contamination. Nutrishare must take prompt corrective action and provide a written response within 15 working days, detailing corrective steps, preventive measures, and supporting documentation, especially regarding the AC units. Failure to comply may lead to legal action, including seizure and injunction, and drugs not meeting 503A conditions would be subject to new drug approval, labeling, and CGMP regulations.